By 2030, it is anticipated that 10 million people in the United States will live with heart failure ( 1/33 people) (Heidenreich et al., 2013, Crit Heart Fail, 6: 606-19; Roger et al., 2012, Circulation, 125: e2-220. However, the available donor hearts remain stagnant at approximately 2000 per year (Stehlik et al., 2010, J Heart Lung Transplant, 39: 1089-103). In recent years, implantable left ventricular assist devices (LVADs) have offered another option to this ill population. Although showing a survival advantage, the earlier pneumatically driven positive displacement pumps showed high mechanical failure due to wear and tear associated with multiple moving parts and associated friction. The technologic improvement of rotary pumps with a single moving part has led to increased durability and patient survival compared with their earlier generations both as a bridge to transplant and as destination therapy. However, the improved durability of rotary blood pumps comes at the compromise of having a pulseless continuous blood flow.
Despite the technologic advances to the pump body, the requirement of a transcutaneous driveline to conduct power (previously needed for shuttling air for pulsatile devices), controller algorithms, and data exchange between the pump and the extracorporeal controller remains unchanged. Despite the benefits of this technology, driveline-associated infections are a common and devastating complication (Sivaratnam and Duggan, 2002, ASAIO J, 48: 2-7; Simon et al., 2005, Clin Infect Dis., 40: 1108-15) that causes a significant negative impact on a patient's quality of life and increased medical cost (Slaughter et al., 2009, N Engl J Med, 361: 2241-51. The presence of nonphysiologic pulseless blood flow in patients with long-term LVAD support has been implicated in increased gastrointestinal bleeding (Pagani et al., 2009, J Am Coll Cardiol, 54: 312-21; Demirozu et al., 2011, J Heart Lung Transplant, 30: 849-53; Crow et al., 2009, J Thorac Cardiovasc Surg, 137: 208-15), limited cardiac unloading (Birks et al., 2006, N Engl J Med, 355: 1873-84; Li et al., 2001, Circulation, 104: 1147-52), vascular malformations (Amir et al., 2006, J Heart Lung Transplant, 25: 391-4; Westaby et al., 2007, J Thorac Cardiovasc Surg, 133: 575-6), and aortic incompetence (Pirbodaghi et al., 2013, Heart Fail Rev; Cowger et al., 2010, 3: 668-74). Moreover, because successful LVAD explantation occurs less often with continuous-flow pumps, concerns have been raised regarding their use in patients with a potential for myocardial recovery.
Thus, there is a need in the art for heart pump devices and systems to provide physiological flow that better mimics the natural heart function. The present invention satisfies this unmet need.